Vanishing Scent Muscle Rub Gel (Menthol) Gel [Mccure Health Solutions Inc.] -

VANISHING SCENT MUSCLE RUB GEL (MENTHOL) GEL [MCCURE HEALTH SOLUTIONS INC.]
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Drug Facts
Active ingredient

Menthol 2.5%

Purpose

Topical analgesic
Uses

temporarily relieves the minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains
Warnings

For external use only.

Do not use

• on wounds or damaged skin • with a heating pad • on a child 12 years of age with arthritis-like conditions

Ask a doctor before use if

you have redness over the affected area

When using this product

• avoid contact with eyes or mucous membranes • do not bandage tightly

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • excessive skin irritation occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.
Directions

• adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 12 years of age: ask a doctor
Other information

• Store between 20 C and 25 C (68 F and 77 F) • Lot No. & Exp. Date. see box or crimp of tube
Inactive ingredients

CARBOMER 940, DL-CAMPHOR, ISOPROPANOL, METHYLPARABEN, POLYSORBATE 60, POTASSIUM SORBATE, PURIFIED WATER, STEARYL ALCOHOL, TROLAMINE
Product Label

INGREDIENTS AND APPEARANCE

VANISHING SCENT MUSCLE RUB GEL
menthol gel

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	25 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 940 (UNII: 4Q93RCW27E)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52486-012-57	1 in 1 CARTON	03/27/2015
1		57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/27/2015

Labeler - McCure Health Solutions Inc. (053034873)

Name	Address	ID/FEI	Business Operations
Establishment
Jiangsu Dedi Medical Device Co., Ltd.		544458936	manufacture(52486-012)

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